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Senior Development Engineer - Pharmaceutical - Cambridgeshire – Permanent
Overview:
Our client is a leading pharmaceutical development and manufacturing organisation at the cutting edge of the industry. At present, they are seeking a Senior Development Engineer to join their engineering group on a permanent basis at their facility in Cambridgeshire. They are looking for suitable candidates to;
- Provide technical leadership for the acquisition and qualification of capital expenditure equipment and systems.
- Project management input and contribution to achievement of project milestones.
- Implementation of pharmaceutical and regulatory requirements for manufacturing processes and equipment.
- Development and validation of manufacturing processes in support for business development and IP generation via proprietary processes or techniques.
- Supporting Manufacturing teams with technical troubleshooting of Fill Finish Processes.
Experience:
- Engineering experience in a GMP environment.
- Degree qualified, preferably Engineering or related subjects
- Specification, selection, and installation of CAPEX equipment.
- Ability to write technical documents including knowledge of regulations and best practices within pharmaceutical manufacturing.
- Validation activities including specification writing, qualification testing and reporting
- Knowledge and/or experience of drug product handling & filling operations for drug delivery devices
- Knowledge of manufacturing process design, scaling, and characterisation
- Knowledge of QbD, DoE and statistical process control methodologies.
- Experience working under the GMP and ISO13485 quality systems
- Experience in risk assessments and risk management
- Aseptic and sterile experience Â
Responsibilities:
- Lead technical projects including generation of specifications, conducting supplier selection, managing the relationship with suppliers during the build phase, and performing commissioning activities.
- Support commissioning and qualification activities of manufacturing equipment, facilities, and utilities including authoring and execution of validation protocols.
- Work with process development and manufacturing functions to translate developed formulations/process’ to final clinical products.
- Perform design feasibility for customer devices and provide engineering solutions to enable technical transfer into the facility whilst ensuring future scalability.
- Provide technical support to the Device Development team to ensure device platforms are compatible with fill-finish systems.
- Keep up to date with market trends and look for better engineering solutions to ensure the company has a competitive edge when it comes to standardised yet adaptable equipment/systems for process development and manufacturing.
- Risk analysis of processes including prioritisation and implementation of mitigations
- Creation of resource plans and costings for customer proposals.
- Generation and communication of reports and presentations
- To work collaboratively with Business Development and other technical colleagues, providing support relating to proposal / project development and direct customer
